JP2013525484A - タンパク質含有製剤の粘度を低減させるために有用な組成物及び方法 - Google Patents

タンパク質含有製剤の粘度を低減させるために有用な組成物及び方法 Download PDF

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JP2013525484A
JP2013525484A JP2013509113A JP2013509113A JP2013525484A JP 2013525484 A JP2013525484 A JP 2013525484A JP 2013509113 A JP2013509113 A JP 2013509113A JP 2013509113 A JP2013509113 A JP 2013509113A JP 2013525484 A JP2013525484 A JP 2013525484A
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protein
antibody
arginine
viscosity
acid
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Japanese (ja)
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JP2013525484A5 (enExample
Inventor
マユミ エヌ． ボーウェン，
チュン リウ，
アンキット アール． パテール，
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ジェネンテック， インコーポレイテッド
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Publication of JP2013525484A5 publication Critical patent/JP2013525484A5/ja
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2812—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD4

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
JP2013509113A 2010-05-03 2011-04-26 タンパク質含有製剤の粘度を低減させるために有用な組成物及び方法 Pending JP2013525484A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US33068910P 2010-05-03 2010-05-03
US61/330,689 2010-05-03
PCT/US2011/034001 WO2011139718A1 (en) 2010-05-03 2011-04-26 Compositions and methods useful for reducing the viscosity of protein-containing formulations

Publications (2)

Publication Number Publication Date
JP2013525484A true JP2013525484A (ja) 2013-06-20
JP2013525484A5 JP2013525484A5 (enExample) 2014-06-19

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JP2013509113A Pending JP2013525484A (ja) 2010-05-03 2011-04-26 タンパク質含有製剤の粘度を低減させるために有用な組成物及び方法

Country Status (10)

Country Link
US (1) US20130058958A1 (enExample)
EP (1) EP2566510A1 (enExample)
JP (1) JP2013525484A (enExample)
KR (1) KR20130060227A (enExample)
CN (1) CN102958538A (enExample)
BR (1) BR112012027828A2 (enExample)
CA (1) CA2794864A1 (enExample)
MX (1) MX2012012743A (enExample)
RU (1) RU2012151500A (enExample)
WO (1) WO2011139718A1 (enExample)

Cited By (8)

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JP2015017042A (ja) * 2013-07-09 2015-01-29 国立大学法人 筑波大学 高濃度γグロブリン製剤の粘度低下方法
JP2016534141A (ja) * 2013-09-11 2016-11-04 アーシア セラピューティクス， インコーポレイテッド 粘度低下剤を含む液状タンパク質製剤
US9574005B2 (en) 2011-07-19 2017-02-21 Chugai Seiyaku Kabushiki Kaisha Stable Protein-containing preparation containing argininamide or analogous compound thereof
JP2017531682A (ja) * 2014-10-23 2017-10-26 アムジエン・インコーポレーテツド 医薬製剤の粘度低下
JP2018535242A (ja) * 2015-11-30 2018-11-29 メディミューン，エルエルシー 高濃度のタンパク質ベースの治療剤を含有する医薬組成物中の非晶質安定化化合物としてのアミノ酸と糖との最適比
JP2021521226A (ja) * 2018-04-16 2021-08-26 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツングＭｅｒｃｋ Ｐａｔｅｎｔ Ｇｅｓｅｌｌｓｃｈａｆｔ ｍｉｔ ｂｅｓｃｈｒａｅｎｋｔｅｒ Ｈａｆｔｕｎｇ 高濃度タンパク質製剤の粘度低下
US11471479B2 (en) 2014-10-01 2022-10-18 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
JP2022548150A (ja) * 2019-09-17 2022-11-16 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツング 高濃縮タンパク質製剤中の粘度低減剤としてのカンファースルホン酸およびそのカチオン性賦形剤との組み合わせ

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AR088579A1 (es) 2011-10-31 2014-06-18 Genentech Inc Formulaciones de anticuerpos
US9169304B2 (en) 2012-05-01 2015-10-27 Pfenex Inc. Process for purifying recombinant Plasmodium falciparum circumsporozoite protein
MX2014014717A (es) * 2012-06-21 2015-03-06 Ucb Pharma Sa Formulacion farmaceutica.
LT3495387T (lt) 2012-07-13 2021-11-25 Roche Glycart Ag Bispecifiniai anti-vegf / anti-ang-2 antikūnai ir jų panaudojimas akių kraujagyslių ligoms gydyti
FR2994390B1 (fr) 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
FR2995214B1 (fr) 2012-09-10 2014-11-21 Adocia Solution a viscosite reduite de proteine a concentration elevee
UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
CN104740630A (zh) * 2013-12-25 2015-07-01 浙江海正药业股份有限公司 一种含有抗cd52单抗的药物组合物
US20160074515A1 (en) 2014-06-20 2016-03-17 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
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US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
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JP7377596B2 (ja) 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法
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ES3036143T3 (en) * 2017-04-28 2025-09-15 Amgen Inc N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
WO2018200533A1 (en) 2017-04-28 2018-11-01 Amgen Inc. Excipients to reduce the viscosity of antibody formulations and formulation compositions
RU2019138507A (ru) 2017-05-02 2021-06-02 Мерк Шарп И Доум Корп. Составы антител против lag3 и совместные составы антител против lag3 и антител против pd-1
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
WO2018211517A1 (en) 2017-05-16 2018-11-22 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
EP3624828B1 (en) * 2017-05-18 2024-08-07 Merck Sharp & Dohme LLC Pharmaceutical formulation comprising incretin-insulin conjugates
WO2019050780A1 (en) 2017-09-05 2019-03-14 Merck Sharp & Dohme Corp. COMPOUNDS FOR REDUCING THE VISCOSITY OF BIOLOGICAL FORMULATIONS
WO2019154776A1 (en) 2018-02-06 2019-08-15 F. Hoffmann-La Roche Ag Treatment of ophthalmologic diseases
JP7235770B2 (ja) 2018-05-10 2023-03-08 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 高濃度ｖｅｇｆ受容体融合タンパク質を含む製剤
CN113056482A (zh) 2018-10-18 2021-06-29 默沙东公司 抗rsv抗体的制剂及其使用方法
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KR20210089215A (ko) 2018-11-07 2021-07-15 머크 샤프 앤드 돔 코포레이션 항-lag3 항체 및 항-pd-1 항체의 공동-제제
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MX2022011892A (es) 2020-03-26 2022-10-18 Univ Vanderbilt Anticuerpos monoclonales humanos dirigidos contra el coronavirus 2 del sindrome respiratorio agudo grave (sars-cov-2).
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